What Are IQ OQ PQ: The 3 Q’s Of Software Validation Process

An Overview of IQ-OQ-PQ:

A part of the Software Verification Procedure consists of IQ, OQ, and PQ

Just as developers are familiar with the knowledge that, the In-house software team develops software based on the Software Requirement Specification (SRS) and function specification. Subsequent to this, the Testing team affirms the implementation at several testing stages in a variety of test environments, spanning from the most elementary to the most advanced– replicating the end production environment. 

Under the framework of the SDLC approach, the software creation team typically submits the adequately tested software to the operations team, who will then deploy it to the production environment and prepare it for end-user usage.

The difficulty here is ensuring that the software is completely operational within the production environment by the Operations team. During the software creation stages, both development and verification are conducted within a simulated environment, that is rarely akin to the live environment unless data and configurations mirroring the production environment are available.

This is where software validation holds importance. Post the successful completion of the verification and official approval of program/product teams, the operations team conducts a series of activities designed to ascertain that the software functions as expected. These are referred to as validation activities.

Verification vs Validation

Lets delineate the differences between ‘Verification’ and ‘Validation’ activities. ‘Verification’ assesses the software with reference to the prescribed set of prerequisites and stipulations, which is conducted in-house at the Software Development site by developers and testers.

Contrastingly, ‘Validation’ is made up of quality assurance checks, executed by external customers, proprietors, and vendors on the delivered product to evaluate its suitability before acceptance or purchase. Typically, validation activities are carried out at the production site.

Within the framework of Application Development, it is the Ops Team that is responsible for carrying out the validation activities for the software.

Recommended Reading:

Verification vs Validation – What’s the Difference and Why It is Important to Understand It

Stages of the Validation Procedure

Typically, the validation process of any product relates to the complete lifecycle of a product from its development, through usage, up to maintenance. The validation process is subdivided into 5 Stages.

The Validation Process Has These 5 Stages:

The 5-stage validation process is adhered to in many sectors including manufacturing, medical, pharmaceuticals, and so on. Validation is performed by end customers before buying the machinery, hardware, or product.
The validation activities for software are conducted to demonstrate that “the software is primed for user consumption” and primarily verify the successful software installation, followed by scrutinising its functionality and operability.

The 3 Q’s methodology: IQ-OQ-PQ

However, within the realm of software, the 3Q’s approach (IQ-OQ-PQ) is utilized as part of the Validation process. These qualifications are performed by the operations team, who handles the software deployment to production.

Illustrated below is the Validation Process Flow Diagram:

The Software Team provides the template, plan, and any other necessary documents to carry out the 3Q’s, including a detailed approach, tasks/activities/tests necessary for these qualifications, and their outcomes. Summarized reports are delivered by the Ops Team during the software handover, along with the software binaries and other deliverables.

In brief:

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In conclusion, conducting IQ, OQ, and PQ aims to ensure a successful software deployment and flawless usage of all functions. These qualifications are sequential activities and must be carried out in a specific sequence. Sometimes, PQ can be initiated concurrently with OQ, provided critical facets of OQ have been accomplished.

Now, we will further discuss these three stages in-depth.

Installing Qualification (IQ)

Also referred to as ‘IQ’, Installation Guidelines involve the process of validating whether the supplied software (binaries, scripts, and so forth) can be installed successfully in a specified environment with the documented configurations. This also verifies how these installation steps are recorded in the ‘Installation Guide.’

The below items are delivered by the development team along with the software package in order for the Ops Team to conduct IQ:

1) An ‘Installation Guide,’ which documents the steps for installation in the chosen environments.

2) ‘Configuration Guide’ detailing how to set up the software’s configurable options. Sometimes, this guide might be included within the installation guide itself.

3) Software package along with Installation scripts, preferably automated scripts.

Software Installation Qualification is viewed as a crucial phase, as issues often arise during this phase. The reason being, the development environment might not be able to access and verify installation issues of a real-time environment, leading to discrepancies between the environment and several issues.

Due to various factors, the collaboration and synchronisation amongst the Development and Operations teams may not be sufficient in the early stages of software development to handle issues proactively. Plus, there might also be some issues with the documentation while logging the actual installation steps in the document, leading to inconsistencies with the production environment.

Today, the entirety of the software installation procedure is oftentimes automated with a set of scripts. If any issues arise during the installation process, the automated installation could fail due to mismatched configurations, demanding manual intervention for troubleshooting those issues.

Therefore, it is imperative for the Software team to ensure that the installation guide is created in such a way that the installation steps correspond accurately with the real-time environment. It is also the duty of the testers to verify the ‘Installation’ procedure in-house, alongside the document verification for completeness and to identify any discrepancies between the recorded steps in the document and the actual steps that are to be carried out on the system.

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SNO Installation Guide Points 1 Ensure that the ‘Installation Guide’ is written in a straightforward and easy-to-understand language. 2 Make sure that the guide is succinct and well-structured, with no more than 5 pages. 3 Assign serial numbers for each step of the execution, making tracking their status easier. 4 As far as possible, automate the steps and group them into a single script. 5 Utilize a standard template for documenting the installation procedure. 6 Clearly mention the pre-requisites along with steps to confirm their existence. Provide instructions to upgrade the system to the expected level or